????2010??GMP??????????????,?GMP????,????????GMP?????????GMP????????????????,???GMP?????GMP?????????????GMP?????????
????2010?GMP??????????????????GMP????PharmaNet???3????? ???????GMP????????????????GMP??,??????????????,??PharmaNet???????GMP?? John Lee ??????????????,???????FDA????????????????????????GMP???????????????????? ???????????????GMP????????
?????????????????GMP???,?????“??FDA GMP??:???????(???)”,????????????????????????????????GMP??,???????FDA?GMP ?????????????????????????????????????????,??????????????????GMP????,???? ???????????
??,????????????????GMP??????????????????????????????????????????????????GMP???????????GMP??????
???????????,?2009?????????????,???“??FDA QSR/GMP??:???????(????)”??????,??????????QSR/GMP?????,??“??FDA QSR/cGMP??:????”,“??FDA QSR/cGMP??:???????(CAPA)”????????????????????
???,??????????????????,???????????????????????????,???? ??GMP?????,??????????????????,??????????????????????????,??????????????? ??????,?????????????????,?????“??FDA cGMP??:???????”????,?????????????????,????????????????
?????GMP??,????????,???????,??????????,??????GMP??????
? ??“????”??,?????????